DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 35 USC § 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As for the 35 USC 112(b) rejections, these previous rejections found in the Office action of February 11, 2026 appear to have been overcome. However, the amended claims have new issues under 35 USC § 112, as detailed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 -17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “optionally measuring an external standard series of the rapid test”, and “optionally also of said external standard series” render the claim indefinite because it is unclear whether the limitations following optionally are part of the claimed invention. See MPEP § 2173.05(h). Because the external standard series is optional, it will be interpreted as a non-required limitation.
Regarding claim 14, the phrases “optionally, an external standard series, wherein the external standard series is measurable by Raman-labeled targets and/or fluorescence-labeled targets” and “optionally, the external standard series” render the claim indefinite because it is unclear whether the limitations following optionally are part of the claimed invention. See MPEP § 2173.05(h). Because the external standard series is optional, it will be interpreted as a non-required limitation.
Regarding claim 16, recites “optionally together with further measured data” renders the claim indefinite because it is unclear whether the limitations following optionally are part of the claimed invention. See MPEP § 2173.05(h). Because together with further measured data is optional, it will be interpreted as a non-required limitation.
Claims 3-13, 16 are vague and indefinite by virtue of its dependence on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 7-10, and 13- 14 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1, disclosed in IDS 02/12/2024 )(hereinafter, “Salehi ”) in view of Ma et al. (“Improved lateral flow strip based on hydrophilic−hydrophobic SERS substrate for ultra−sensitive and quantitative immunoassay”, 2020)(hereinafter, “Ma”), further in view of Zhang et al. (“Stable Graphene-Isolated-Au-Nanocrystal for Accurate and Rapid Surface Enhancement Raman Scattering Analysis”, 2016)(hereinafter, “Zhang”).
Regarding claim 1, Salehi teaches a method for the absolute quantification (teaches a method that uses surface-enhanced Raman scattering (SERS) combined with nanomaterials for the quantification of proteins, [0069-0070]) of at least one analyte (protein analytes such as BSA and IgG, [0063] and [0069], teaches quantitative measurement of protein/nanoparticles, [0059] and [0069]), including spectroscopic determination (uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]), comprising the steps of:
using at least one nanomaterial as a luminescent substance for quantification (teaches gold nanoparticles, used as SERS-active probes, [0047]), wherein the at least one nanomaterial interacts directly or indirectly with the analyte ([0063] teaches IgG is covalently coupled to surface of SERS nanoparticles),
wherein the nanomaterial is a Raman-active material (teaches gold nanoparticles, used as SERS-active probes, [0047]) , and the spectroscopic determination is carried out by surface-enhanced Raman scattering (SERS) (“protein determination can be directly determined by SERS signals”, “the SERS spectra (at about 1340 cm -1 ) were normalized to the plastic band”, [0069-0070]),
measuring at least one signal generated by the nanomaterial ([0069]),
measuring Raman background signals from a plastic part (figure 7A, [0070]), a plastic housing and/or a nitrocellulose membrane of the rapid test as the target to be measured for measuring an internal standard series by which a constant measurement signal can be measured for defined measurement parameters independently of the concentration of the analyte,
optionally measuring an external standard series of the rapid test, and subsequently
standardizing the generated signal of the nanomaterial using said measured internal (“the SERS spectra (at about 1340 cm -1 ) were normalized to the plastic band”, [0070]) and optionally also of said external standard series.
Salehi fails to disclose a rapid test; wherein the rapid test is a lateral flow assay or a vertical flow assay, and so that an absolute quantification of the analyte is achieved; generating said internal standard series from the Raman background signals by measuring the background signals at different laser powers and/or with a changed laser focus to obtain a plurality of measurements of the standard series.
Ma teaches a rapid test including spectroscopic determination (disclose “a novel PDMS-based LFIA, section, introduction); wherein the rapid test is a lateral flow assay (disclose “the LFIA strip after washing was used for following SERS measurement”, section 2.3. Quantitative detection of FER by FILA) or a vertical flow assay, and so that an absolute quantification of the analyte is achieved (discloses a quantitative calibration and determines LOD of 0.41 pg/mL, section results and discussion).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate PDMS based LFIA of Ma to Salehi to improve sensitivity and quantitative accuracy.
Zhang teaches generating said internal standard series from the Raman background signals (“Raman spectra of Raman spectra of CV exposed to 532 nm laser for different seconds”, figure 3, section Raman Analysis with GIAN as an Internal Standard) by measuring the background signals (discloses the GIAN graphene 2D band at about 2700 cm−1 as the internal standard, figure 3, section Raman Analysis with GIAN as an Internal Standard) at different laser powers (section Raman Analysis with GIAN as an Internal Standard) and/or with a changed laser focus to obtain a plurality of measurements of the standard series.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate internal-standard normalization of Zhang into Salehi in view of Ma to improve quantitative accuracy.
Regarding claim 4, Salehi teaches wherein the measurement of the internal and/or the external standard series is carried out using Raman-labelled targets (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046]. The Raman labeled nanoparticles are used for SERS based detection and quantification, [0069-0070]) and/or fluorescence-labelled targets.
Regarding claim 5, Salehi teaches wherein, in order to measure an internal standard series(the plastic background signal is measured and used as an internal standard series, [0071]), the at least one target is measured with different intensities of an irradiated light (teaches measuring a plastic background under different laser conditions (exposure time), [0071]), so that a plurality of measurements of a standard series are obtained (teaches uses the plastic background Raman signal as an internal standard to automatically correct /normalize the SERS signal of the analyte, [0071]).
Regarding claim 7, Salehi teaches wherein at least one nanomaterial as luminescent substance (teaches gold nanoparticles, used as SERS-active probes, [0047]) is an IgG-coupled Raman-active nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046]), and/or the measurement of the signal generated by the nanomaterial is carried out by surface-enhanced Raman scattering, so that the generated signal is a surface-enhanced Raman scattering signal (uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for protein quantification, [0046] and [0069-0070]).
Regarding claim 8, Salehi teaches wherein the rapid test is a lateral flow assay or a vertical flow assay or Western blot and/or quantum dots upconversion and/or nanomaterials are used for the quantification of the analyte(uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for analyte quantification, [0046] and [0069-0070]), the nanomaterials being coated with a self-assembling single layer or a monolayer of organic molecules as Raman markers (uses gold nanoparticles functionalized with 4-MBA, which serves as the Raman marker for SERS signal detection, [0046] and [0069-0070]) and/or such materials or nanomaterials being coupled to ligands, such as protein A, protein G, protein A/G, protein L, biotinylated antibodies or enzyme-coupled and fluorescent antibodies, for the quantification of the analyte.
Regarding claim 9, Salehi teaches wherein the at least one nanomaterial is a nanocrystalline luminescent substance which comprises LaPO4:Ce3+, LaPO4:Pr3+, LuPO4:Pr3+, LaPO4:Tm3+ LuPO4:Dy3+, LuPO4:EU3+, LuPO4:Tb3+, LuPO4:Tm3+ and is formed therefrom and/or that the at least one nanomaterial is a nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046-0047]) or microparticles produced by doping, from a plastic polymer.
Regarding claim 10, Salehi teaches wherein the measurement is carried out by a UV, UV-VIS, IR, fluorescence and/or Raman spectrometer (uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]).
Regarding claim 13, Salehi teaches characterized by a simultaneous (discloses both plastic Raman band (internal standard) and proteins SERS signal (analyte) are captured simultaneously in the same Raman spectrum, [0070-0072]) or immediately successive exposure of the standard series and the at least one nanomaterial (gold nanoparticles that have been functionalized with a Raman reporter molecule, 4- mercaptobenzoic acid (4-MBA), [0046-0047]) by spectroscopy in a spectrum range from UV to IR (uses both UV/VIS and SERS, which fall within the UV to IR spectrum range, [0047] and [0069-0070]).
Regarding claim 14, Salehi teaches device for the absolute quantification(teaches a filtration/dialysis device for separating and quantifying protein analytes using SERS and internal standard normalization, [0069-0071]) of at least one analyte(protein analytes such as BSA and IgG, [0063] and [0069]) combined with immediate spectroscopy, [0069-0074]) that uses surface-enhanced Raman scattering ([0069-0071]), with
at least one nanomaterial as a luminescent substance for quantification, which interacts directly or indirectly with the analyte(uses gold nanoparticles functionalized with 4-MBA as SERS-active probes, and the signal generated by these nanoparticles is a SERS signal, which is used for protein quantification, [0046] and [0069-0070]), measured by a spectrometer (uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]) in order to measure at least one surface-enhanced Raman scattering (SERS) signal generated by the nanomaterial (“protein determination can be directly determined by SERS signals”, “the SERS spectra (at about 1340 cm -1 ) were normalized to the plastic band”, [0069-0070]), Raman background signals from a plastic part (figure 7A, [0070]), a plastic housing and/or a nitrocellulose membrane of the rapid test, and, optionally, an external standard series, wherein the external standard series is measurable by Raman-labeled targets and/or fluorescence-labeled targets, and
data processing device (discloses processing measurement signals (UV/VIS and SERS), [0047] and [0069-0070], that inherently require instrumentation with data processing).
Salehi fails to disclose a rapid test; wherein the rapid test is a lateral flow assay or a vertical flow assay, and so that an absolute quantification of the analyte is achieved; wherein the Raman background signals are measured at different laser powers and/or with a changed laser focus to obtain a plurality of Raman background measurements, generate an internal standard series from the plurality of Raman background measurements and to standardize or to reference the concentration of the analyte using the internal standard series and, optionally, the external standard series.
Ma teaches a rapid test including spectroscopic determination (disclose “a novel PDMS-based LFIA, section, introduction); wherein the rapid test is a lateral flow assay (disclose “the LFIA strip after washing was used for following SERS measurement”, section 2.3. Quantitative detection of FER by FILA) or a vertical flow assay, and so that an absolute quantification of the analyte is achieved (discloses a quantitative calibration and determines LOD of 0.41 pg/mL, section results and discussion).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate PDMS based LFIA of Ma to Salehi to improve sensitivity and quantitative accuracy.
Zhang teaches wherein the Raman background signals (discloses the GIAN graphene 2D band at about 2700 cm−1 as the internal standard, figure 3, section Raman Analysis with GIAN as an Internal Standard) are measured at different laser powers (“Raman spectra of Raman spectra of CV exposed to 532 nm laser for different seconds”, figure 3, section Raman Analysis with GIAN as an Internal Standard) and/or with a changed laser focus to obtain a plurality of Raman background measurements, generate an internal standard series from the plurality of Raman background measurements (“Raman spectra of Raman spectra of CV exposed to 532 nm laser for different seconds”, figure 3, section Raman Analysis with GIAN as an Internal Standard) and to standardize (section Raman Analysis with GIAN as an Internal Standard) or to reference the concentration of the analyte using the internal standard series and, optionally, the external standard series.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate internal-standard normalization of Zhang into Salehi in view of Ma to improve quantitative accuracy.
Claims 3, 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of Ma et al. (“Improved lateral flow strip based on hydrophilic−hydrophobic SERS substrate for ultra−sensitive and quantitative immunoassay”, 2020)(hereinafter, “Ma”), in view of Zhang et al. (“Stable Graphene-Isolated-Au-Nanocrystal for Accurate and Rapid Surface Enhancement Raman Scattering Analysis”, 2016)(hereinafter, “Zhang”), further in view of Alderman et al. (US Pub 2015/0031047 A1)(hereinafter, “Alderman”).
Regarding claim 3, Salehi teaches wherein a control line is measured to measure an internal standard series (teaches constant Raman signal from plastic background (e.g., at 1000
c
m
-
1
), [0070]) and the measured value obtained is used as a reference value (teaches the Raman signal of nanomaterial is corrected by constant plastic signal, [0071])for standardization of the generated signal of the nanomaterial(plastic substrate Raman signal, then subsequently uses it to correct/normalize the SERS signals, [0070-0071]).
Salehi fails to disclose a rapid test; with a supplementary calculation of the analyte using a 4-parameter logistic .
Ma teaches a rapid test including spectroscopic determination (disclose “a novel PDMS-based LFIA, section, introduction).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate PDMS based LFIA of Ma to Salehi to improve sensitivity and quantitative accuracy.
Alderman in the field of biochemical assays and molecular diagnostics teaches a supplementary calculation of the analyte using a 4-parameter logistic (teaches the assay output (AMMP signal) is plotted vs. log(dilution) and fit to a 4-parameter logistic equation to determine analyte concentration, [0155-0157].
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate a 4-parameter logistic (4PL) model of Alderman to Salehi in view of Ma in view of Zhang to enhance the accuracy of analyte quantification ([0153]).
Regarding claim 6, Salehi teaches all limitations of claim 1 but fails to teach wherein for a measurement of an external standard series a plurality of measuring surfaces are provided, each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial, the signal-active material and/or the nanomaterial being particularly preferably immobilized on an attachment or on the rapid test and optionally sealed.
Alderman in the field of biochemical assays and molecular diagnostics teaches wherein for a measurement of an external standard series(the set of prepared, calibrated bead-based assay standards (e.g., beads with immobilized preprooxytocin or known recombinant oxytocin) at known concentrations used to generate a standard curve, [0207], and [0219-0222] ) a plurality of measuring surfaces are provided (teaches multiple beads with different immobilized materials as measuring surface in the system, [0220] and [0235]), each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial (teaches different beads carry different amounts of immobilized protein and fluorescent antibody, ([0218-0220]), the signal-active material (proteins, antibodies, [0216-0217]) and/or the nanomaterial being particularly preferably immobilized on an attachment (teaches bead-immobilized oxytocin prepropeptide, [0218]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate an external standard series a plurality of measuring surfaces of Alderman to Salehi in view of in view of Ma in view of Zhang to enhance the generation of calibrated standard curves, thereby improving the accuracy and reliability of absolute quantification of the analyte ([0207] and [0221]).
Regarding claim 17, Salehi teaches method for the absolute quantification(teaches a filtration/dialysis device for separating and quantifying protein analytes using SERS and internal standard normalization, [0069-0071]) of at least one analyte (protein analytes such as BSA and IgG, [0063] and [0069]) including spectroscopic determination(uses UV/VIS and Raman spectrometers for protein quantification via SERS, [0047] and [0069-0070]), comprising the steps of:
using at least one nanomaterial as a luminescent substance for quantification (teaches gold nanoparticles, used as SERS-active probes, [0047]),
wherein the at least one nanomaterial interacts directly or indirectly with the analyte ([0063] teaches IgG is covalently coupled to surface of SERS nanoparticles),
wherein the nanomaterial is a Raman-active material (teaches gold nanoparticles, used as SERS-active probes, [0047]), and the spectroscopic determination is carried out by surface-enhanced Raman scattering (SERS) (“protein determination can be directly determined by SERS signals”, “the SERS spectra (at about 1340 cm -1 ) were normalized to the plastic band”, [0069-0070]),
measuring at least one signal generated by the nanomaterial([0069]),
measuring Raman background signals from a plastic part (figure 7A, [0070]), a plastic housing and/or a nitrocellulose membrane of the rapid test,
standardizing the generated signal using said measured internal standard series (“the SERS spectra (at about 1340 cm -1 ) were normalized to the plastic band”, [0070]).
Salehi fails to disclose a rapid test; wherein the rapid test is a lateral flow assay or a vertical flow assay, generating an internal standard series from the Raman background signals by measuring the background signals at different laser powers and/or with a changed laser focus to obtain a plurality of measurements, measuring an external standard series of the rapid test, wherein for a measurement of an external standard series a plurality of measuring surfaces are provided, each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial, the signal-active material and/or the nanomaterial being immobilized on an attachment separate from the rapid test, and external standard series, so that an absolute quantification of the analyte is achieved.
Ma teaches a rapid test including spectroscopic determination (disclose “a novel PDMS-based LFIA, section, introduction); wherein the rapid test is a lateral flow assay (disclose “the LFIA strip after washing was used for following SERS measurement”, section 2.3. Quantitative detection of FER by FILA) or a vertical flow assay, and so that an absolute quantification of the analyte is achieved (discloses a quantitative calibration and determines LOD of 0.41 pg/mL, section results and discussion).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate PDMS based LFIA of Ma to Salehi to improve sensitivity and quantitative accuracy.
Zhang teaches generating an internal standard series from the Raman background signals (“Raman spectra of Raman spectra of CV exposed to 532 nm laser for different seconds”, figure 3, section Raman Analysis with GIAN as an Internal Standard) by measuring the background signals (discloses the GIAN graphene 2D band at about 2700 cm−1 as the internal standard, figure 3, section Raman Analysis with GIAN as an Internal Standard) at different laser powers (section Raman Analysis with GIAN as an Internal Standard) and/or with a changed laser focus to obtain a plurality of measurements of the standard series.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate internal-standard normalization of Zhang into Salehi in view of Ma to improve quantitative accuracy.
Alderman in the field of biochemical assays and molecular diagnostics teaches wherein for a measurement of an external standard series(the set of prepared, calibrated bead-based assay standards (e.g., beads with immobilized preprooxytocin or known recombinant oxytocin) at known concentrations used to generate a standard curve, [0207], and [0219-0222] ) a plurality of measuring surfaces are provided (teaches multiple beads with different immobilized materials as measuring surface in the system, [0220] and [0235]), each with a different concentration of a separately prepared signal-active material and/or at least one nanomaterial (teaches different beads carry different amounts of immobilized protein and fluorescent antibody, ([0218-0220]), the signal-active material (proteins, antibodies, [0216-0217]) and/or the nanomaterial being immobilized on an attachment (teaches bead-immobilized oxytocin prepropeptide, [0218]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate an external standard series a plurality of measuring surfaces of Alderman to Salehi in view of in view of Ma in view of Zhang to enhance the generation of calibrated standard curves, thereby improving the accuracy and reliability of absolute quantification of the analyte ([0207] and [0221]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of Ma et al. (“Improved lateral flow strip based on hydrophilic−hydrophobic SERS substrate for ultra−sensitive and quantitative immunoassay”, 2020)(hereinafter, “Ma”), in view of Zhang et al. (“Stable Graphene-Isolated-Au-Nanocrystal for Accurate and Rapid Surface Enhancement Raman Scattering Analysis”, 2016)(hereinafter, “Zhang”), further in view of Lambert et al. (US Pub 2010/0055721 A1)(hereinafter, “Lambert”).
Regarding claim 11, Salehi teaches all limitations of claim 1 but fails to teach wherein a measurement and in particular a spectroscopic examination of a positive and a negative control is carried out in parallel with the measurement of the signal of the nanocrystalline luminescent substance generated by the nanomaterial.
Lambert in the field of biochemical sensing and analytical diagnostics teaches wherein a measurement(teaches Raman spectral measurements to detect analytes in biosensors and lateral flow assays, [0145] and [0151]) and in particular a spectroscopic examination(teaches spectroscopic techniques such as fluorescence lifetime measurements and SERS, [0145] and [0150-0153]) of a positive and a negative control is carried out in parallel (teaches the distinct strips each containing specific SERS nanoparticle-antibody conjugates as positive controls by detection of their target analytes, the absence or reduction of signal in other strips, such as those with diluted mixtures or non-target conjugates, as negative/baseline controls. Since all these strips are run simultaneously on the same lateral flow membrane, the system inherently performs parallel measurements of positive and negative conditions within the same assay run, [0154-0156]) with the measurement of the signal of the nanocrystalline luminescent substance generated by the nanomaterial (teaches SERS tags comprise a metal (gold/silver) nanoparticle coated with a highly adsorbing SERS active chemical 710, [0153]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate parallel spectroscopic examination of positive and negative controls of Lambert to Salehi in view of in view of Ma in view of Zhang to enhance accurate quantification via Raman spectral analysis, thereby improving both the accuracy and robustness of the assay ([0156]).
Regarding claim 12, Salehi teaches all limitations of claim 1 but fails to teach wherein at least one nanocrystalline luminescent substance is used for measuring the standard series and/or at least one fluorescent dye is used as luminescent substance for quantifying the analyte.
Lambert in the field of biochemical sensing and analytical diagnostics teaches wherein at least one nanocrystalline luminescent substance(teaches SERS tags comprise a metal (gold/silver) nanoparticle coated with a highly adsorbing SERS active chemical 710, [0153]) is used for measuring the standard series (teaches the array of strips each with known SERS nanoparticle conjugates (single analytes and mixtures) at defined concentrations, used for calibration and quantification, [0154-0155]) and/or at least one fluorescent dye is used as luminescent substance for quantifying the analyte.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate the use of nanocrystalline luminescent substances in the measurement of the standard series of Lambert to Salehi in view of in view of Ma in view of Zhang to enhance sensitivity, multiplexing capability, and signal clarity, thereby improving the accuracy and reliability of analyte quantification ([0150-0158]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Salehi et al. (EP 3034616 A1)(hereinafter, “Salehi ”) in view of Ma et al. (“Improved lateral flow strip based on hydrophilic−hydrophobic SERS substrate for ultra−sensitive and quantitative immunoassay”, 2020)(hereinafter, “Ma”), in view of Zhang et al. (“Stable Graphene-Isolated-Au-Nanocrystal for Accurate and Rapid Surface Enhancement Raman Scattering Analysis”, 2016)(hereinafter, “Zhang”), further in view of Niedenzu et al. (WO 2013/189860 A2)(hereinafter, “Niedenzu”).
Regarding claim 16, Salehi teaches absolutely quantified measured values (teaches a method that uses surface-enhanced Raman scattering (SERS) combined with nanomaterials to generate quantitative data on protein analytes, [0069-0070]), optionally together with further measured data and/or parameters of the patient including age, gender, previous illnesses, vital functions, and/or routine laboratory results, in a database.
Salehi fails to disclose using said stored data to adjust or personalize the medication dose or to make dosing recommendations for medications or active ingredients for future patients.
Niedenzu in the field of medical diagnostics and drug administration verification technology teaches using said stored data (spectroscopically acquired data, [page 45, lines 28-31], [page 46, lines 3-20], [page 47, lines 33-36] , [page 48, lines 11- 15 and 42-45]) to adjust or personalize the medication dose (detects exact concentrations (e.g., 1.49% vs. 1.51% KCI), flags unexpected concentrations, which helps inform correct dosing, page 46, lines 43-46) or to make dosing recommendations for medications or active ingredients for future patients.
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a method to adjust the medication dose of Niedenzu to Salehi in view of in view of Ma in view of Zhang’s absolutely quantified measured values to enables the detection of incorrect dosing, provides real-time feedback to users, and supports corrective actions to optimize therapeutic outcomes ([page 45, line 24] and [ page 47, lines 22-36]).
Conclusion
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/C.X./ Examiner, Art Unit 2877
/Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877
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